Medivators, Inc.
Medical device manufacturer in Minneapolis, MN.
13510(k) clearances
0PMA approvals
9recalls
Device types
- FEB Accessories, Cleaning, For Endoscope 4
- OCX Endoscopic Irrigation/Suction System 2
- NVE Washer, Cleaner, Automated, Endoscope 1
- MED Sterilant, Medical Devices 1
- NIH Disinfectant, Subsystem, Water Purification 1
- KTI Bronchoscope Accessory 1
- JOJ Indicator, Physical/Chemical Sterilization… 1
- FED Endoscopic Access Overtube, Gastroenterology… 1
- FAJ Cystoscope And Accessories, Flexible/Rigid 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | 08/14/2023SE |
| K223040 | Endo SmartCapFAJ · Special | 03/01/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | 01/14/2022SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | 12/19/2017SE |
| K162128 | Scope Buddy Plus Endoscope Flushing AidFEB · Traditional | 12/21/2016SE |
| K160846 | AmplifEYEFED · Traditional | 07/14/2016SE |
| K152394 | Rapicide PA High-Level Disinfectant Test StripsJOJ · Traditional | 03/11/2016SE |
| K151522 | DEFENDO Bronchoscopy Suction ValveKTI · Traditional | 09/17/2015SE |
| K133724 | Minncare HDNIH · Traditional | 08/27/2014SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | 07/15/2014SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | 08/17/2000SE |
| K914145 | DSD-91(TM) Disinfector for Flexible EndoscopesFEB · Traditional | 02/22/1994SE |
| K862402 | Ott Disinfector for Flexible EndoscopesNVE · Traditional | 02/03/1987SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1859-2021 Class II | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction…The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of… | 04/20/2021Terminated |
| Z-1778-2020 Class II | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1777-2020 Class II | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1776-2020 Class II | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1775-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1774-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1773-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1772-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-2761-2015 Class II | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The…Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. | 08/03/2015Terminated |